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Jeanne Garric - One of the best experts on this subject based on the ideXlab platform.
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Environmental risk assessment for the serotonin re uptake inhibitor fluoxetine case study using the european risk assessment framework
Integrated Environmental Assessment and Management, 2010Co-Authors: K.d. Oakes, Thomas Knacker, Jeanne Garric, A. Coors, B.i. Escher, Kathrin Fenner, M. Gust, Anette Kuster, Carola KussatzAbstract:The serotonin re-uptake inhibitor fluoxetine was selected for an Environmental risk assessment, using the most recent European guideline (EMEA 2006) within the European Union (EU)-funded Environmental Risk Assessment of Pharmaceuticals (ERAPharm) project due to its Environmental persistence, acute toxicity to nontarget organisms, and unique pharmacokinetics associated with a readily ionizable compound. As a widely prescribed psychotropic drug, fluoxetine is frequently detected in surface waters adjacent to urban areas because municipal wastewater effluents are the primary route of entry to aquatic environments. In Phase I of the assessment, the initial Predicted Environmental Concentration of fluoxetine in surface water (initial PECSW) reached or exceeded the action limit of 10 ng/L, when using both a default market penetration factor and prescription data for Sweden, Germany, and the United Kingdom. Consequently, a Phase II risk assessment was conducted in which green algae were identified as the most sensitive species with a NOEC of <0.6 µg/L. From this value, a Predicted no effect Concentration for surface waters (PNECSW) of 0.012 µg/L was derived. The PEC/PNEC ratio was above the trigger value of 1 in worst-case exposure scenarios indicating a potential risk to the aquatic compartment. Similarly, risks of fluoxetine for sediment-dwelling organisms could not be excluded. No risk assessment was conducted for the terrestrial compartment due to a lack of data on effects of fluoxetine on soil organisms. The need for a separate risk assessment for the main metabolite of fluoxetine, norfluoxetine, was not conducted because of a lack of fate and effect studies. Based on published data, fluoxetine and norfluoxetine appeared to have a low to moderate bioaccumulation potential, which should be confirmed in formal studies according to OECD guidelines. Exposure assessments for fluoxetine according to the current framework rely heavily on KOC and KOW values. This approach is problematic, because fluoxetine is predominantly a cationic substance at Environmental pH values. Consequently, the fate of fluoxetine (and other ionic substances) cannot be Predicted using partition coefficients established for nonionic compounds. Further, published estimates for partition coefficients of fluoxetine vary, resulting in considerable uncertainties in both the exposure and Environmental risk assessments of fluoxetine. Integr Environ Assess Manag 2010;6:524–539. © 2009 SETAC
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Environmental risk assessment for the serotonin re uptake inhibitor fluoxetine: Case study using the european risk assessment framework
Integrated Environmental Assessment and Management, 2010Co-Authors: K.d. Oakes, Jeanne Garric, A. Coors, B.i. Escher, Kathrin Fenner, M. Gust, T. Knacker, Alice Kuster, C. Kussatz, C.d. MetcalfeAbstract:The serotonin re-uptake inhibitor fluoxetine was selected for an Environmental risk assessment, using the most recent European guideline (EMEA 2006) within the European Union (EU)-funded Environmental Risk Assessment of Pharmaceuticals (ERAPharm) project due to its Environmental persistence, acute toxicity to nontarget organisms, and unique pharmacokinetics associated with a readily ionizable compound. As a widely prescribed psychotropic drug, fluoxetine is frequently detected in surface waters adjacent to urban areas because municipal wastewater effluents are the primary route of entry to aquatic environments. In Phase I of the assessment, the initial Predicted Environmental Concentration of fluoxetine in surface water (initial PECSW) reached or exceeded the action limit of 10 ng/L, when using both a default market penetration factor and prescription data for Sweden, Germany, and the United Kingdom. Consequently, a Phase II risk assessment was conducted in which green algae were identified as the most sensitive species with a NOEC of
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Environmental Risk Assessment of Human Pharmaceuticals in the European Union: A Case Study with the beta-blocker Atenolol
Integrated Environmental Assessment and Management, 2010Co-Authors: Alice Kuster, Jeanne Garric, Kathrin Fenner, A.c. Alder, B. Escher, K. Duis, T.h. Hutchinson, D.r. Lapen, A. Pery, J. RömbkeAbstract:Beta-adrenergic receptor blockers (β-blockers) are applied to treat high blood pressure, ischemic heart disease and heart rhythm disturbances. Due to their widespread use and limited human metabolism β-blockers are widely detected in sewage effluents and surface waters. β-adrenergic receptors have been characterised in fish and other aquatic animals and, therefore, it can be expected that physiological processes regulated by these receptors in wild animals may be affected by the presence of β-blockers. As ecotoxicological data on β-blockers are scarce, it was decided to choose the β-blocker atenolol as a case study pharmaceutical within the project ERAPharm. Starting point for the assessment of potential Environmental risks was the European guideline on the Environmental risk assessment of medicinal products for human use. In Phase I of the risk assessment, the initial Predicted Environmental Concentration (PEC) of atenolol in surface water (500 ng L-1) exceeded the action limit of 10 ng L-1. Thus, a phase II risk assessment was conducted showing acceptable risks for surface water, groundwater and for aquatic microorganisms. Furthermore, atenolol showed a low potential for bioaccumulation as indicated by its low lipophilicity (log Kow = 0.16), a low potential for exposure of the terrestrial compartment via sludge (log Koc = 2.17) and a low affinity for sorption to the sediment. Thus, the risk assessment according to Phase II-Tier A did not reveal any unacceptable risk for atenolol. Beyond the requirements of the guideline, additional data on effects and fate were generated within ERAPharm. A two-generation reproduction test with the waterflea Daphnia magna resulted in the most sensitive NOEC of 1.8 mg L-1. However, even with this NOEC a risk quotient of 0.003 was calculated, which is still well below the risk threshold limit of 1. The additional studies confirm the outcome of the Environmental risk assessment according to EMEA/CHMP (2006). However, atenolol should not be considered as representative for other β-blockers, such as metoprolol, oxprenolol and propranolol some of which show significantly different physico-chemical characteristics and varying toxicological profiles in mammalian studies.
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ecotoxicological impact of pharmaceuticals found in treated wastewaters study of carbamazepine clofibric acid and diclofenac
Ecotoxicology and Environmental Safety, 2003Co-Authors: Benoit J D Ferrari, Nicklas Paxeus, Roberto Lo Giudice, Antonino Pollio, Jeanne GarricAbstract:In four countries (France, Greece, Italy, and Sweden) occurrence in sewage treatment plant (STP) effluents and ecotoxicity of the pharmaceuticals carbamazepine, clofibric acid, and diclofenac were investigated. Bioassays were performed on bacteria, algae, microcrustaceans, and fishes in order to calculate their Predicted no-effect Concentrations (PNEC) and to perform a first approach of risk characterization. For this aim, risk has been estimated by the Predicted Environmental Concentration/PNEC ratio and the measured Environmental Concentration/PNEC ratio. First, regarding the PNEC, carbamazepine appears to be the more hazardous compound. Second, even though it is demonstrated that carbamazepine, clofibric acid, and diclofenac have been detected in effluents, only carbamazepine have been detected in all sewage treatment plants with the greatest Concentrations. Third, risk quotients greater than unity were calculated only for carbamazepine, suggesting that risk for the water compartment is expected.
B.i. Escher - One of the best experts on this subject based on the ideXlab platform.
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Environmental risk assessment for the serotonin re uptake inhibitor fluoxetine case study using the european risk assessment framework
Integrated Environmental Assessment and Management, 2010Co-Authors: K.d. Oakes, Thomas Knacker, Jeanne Garric, A. Coors, B.i. Escher, Kathrin Fenner, M. Gust, Anette Kuster, Carola KussatzAbstract:The serotonin re-uptake inhibitor fluoxetine was selected for an Environmental risk assessment, using the most recent European guideline (EMEA 2006) within the European Union (EU)-funded Environmental Risk Assessment of Pharmaceuticals (ERAPharm) project due to its Environmental persistence, acute toxicity to nontarget organisms, and unique pharmacokinetics associated with a readily ionizable compound. As a widely prescribed psychotropic drug, fluoxetine is frequently detected in surface waters adjacent to urban areas because municipal wastewater effluents are the primary route of entry to aquatic environments. In Phase I of the assessment, the initial Predicted Environmental Concentration of fluoxetine in surface water (initial PECSW) reached or exceeded the action limit of 10 ng/L, when using both a default market penetration factor and prescription data for Sweden, Germany, and the United Kingdom. Consequently, a Phase II risk assessment was conducted in which green algae were identified as the most sensitive species with a NOEC of <0.6 µg/L. From this value, a Predicted no effect Concentration for surface waters (PNECSW) of 0.012 µg/L was derived. The PEC/PNEC ratio was above the trigger value of 1 in worst-case exposure scenarios indicating a potential risk to the aquatic compartment. Similarly, risks of fluoxetine for sediment-dwelling organisms could not be excluded. No risk assessment was conducted for the terrestrial compartment due to a lack of data on effects of fluoxetine on soil organisms. The need for a separate risk assessment for the main metabolite of fluoxetine, norfluoxetine, was not conducted because of a lack of fate and effect studies. Based on published data, fluoxetine and norfluoxetine appeared to have a low to moderate bioaccumulation potential, which should be confirmed in formal studies according to OECD guidelines. Exposure assessments for fluoxetine according to the current framework rely heavily on KOC and KOW values. This approach is problematic, because fluoxetine is predominantly a cationic substance at Environmental pH values. Consequently, the fate of fluoxetine (and other ionic substances) cannot be Predicted using partition coefficients established for nonionic compounds. Further, published estimates for partition coefficients of fluoxetine vary, resulting in considerable uncertainties in both the exposure and Environmental risk assessments of fluoxetine. Integr Environ Assess Manag 2010;6:524–539. © 2009 SETAC
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Environmental risk assessment for the serotonin re uptake inhibitor fluoxetine: Case study using the european risk assessment framework
Integrated Environmental Assessment and Management, 2010Co-Authors: K.d. Oakes, Jeanne Garric, A. Coors, B.i. Escher, Kathrin Fenner, M. Gust, T. Knacker, Alice Kuster, C. Kussatz, C.d. MetcalfeAbstract:The serotonin re-uptake inhibitor fluoxetine was selected for an Environmental risk assessment, using the most recent European guideline (EMEA 2006) within the European Union (EU)-funded Environmental Risk Assessment of Pharmaceuticals (ERAPharm) project due to its Environmental persistence, acute toxicity to nontarget organisms, and unique pharmacokinetics associated with a readily ionizable compound. As a widely prescribed psychotropic drug, fluoxetine is frequently detected in surface waters adjacent to urban areas because municipal wastewater effluents are the primary route of entry to aquatic environments. In Phase I of the assessment, the initial Predicted Environmental Concentration of fluoxetine in surface water (initial PECSW) reached or exceeded the action limit of 10 ng/L, when using both a default market penetration factor and prescription data for Sweden, Germany, and the United Kingdom. Consequently, a Phase II risk assessment was conducted in which green algae were identified as the most sensitive species with a NOEC of
Carola Kussatz - One of the best experts on this subject based on the ideXlab platform.
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toxicity of the fluoroquinolone antibiotics enrofloxacin and ciprofloxacin to photoautotrophic aquatic organisms
Environmental Toxicology and Chemistry, 2011Co-Authors: Ina Ebert, Jean Bachmann, Ute Kuhnen, Anette Kuster, Carola Kussatz, Dirk Maletzki, Christoph SchluterAbstract:The present study investigated the growth inhibition effect of the fluoroquinolone antibiotics enrofloxacin and ciprofloxacin on four photoautotrophic aquatic species: the freshwater microalga Desmodesmus subspicatus, the cyanobacterium Anabaena flos-aquae, the monocotyledonous macrophyte Lemna minor, and the dicotyledonous macrophyte Myriophyllum spicatum. Both antibiotics, which act by inhibiting the bacterial DNA gyrase, demonstrated high toxicity to A. flos-aquae and L. minor and moderate to slight toxicity to D. subspicatus and M. spicatum. The cyanobacterium was the most sensitive species with median effective Concentration (EC50) values of 173 and 10.2 µg/L for enrofloxacin and ciprofloxacin, respectively. Lemna minor proved to be similarly sensitive, with EC50 values of 107 and 62.5 µg/L for enrofloxacin and ciprofloxacin, respectively. While enrofloxacin was more toxic to green algae, ciprofloxacin was more toxic to cyanobacteria. Calculated EC50s for D. subspicatus were 5,568 µg/L and >8,042 µg/L for enrofloxacin and ciprofloxacin, respectively. These data, as well as effect data from the literature, were compared with Predicted and reported Environmental Concentrations. For two of the four species, a risk was identified at ciprofloxacin Concentrations found in surface waters, sewage treatment plant influents and effluents, as well as in hospital effluents. For ciprofloxacin the results of the present study indicate a risk even at the Predicted Environmental Concentration. In contrast, for enrofloxacin no risk was identified at Predicted and measured Concentrations. Environ. Toxicol. Chem. 2011;30:2786–2792. © 2011 SETAC
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Environmental risk assessment for the serotonin re uptake inhibitor fluoxetine case study using the european risk assessment framework
Integrated Environmental Assessment and Management, 2010Co-Authors: K.d. Oakes, Thomas Knacker, Jeanne Garric, A. Coors, B.i. Escher, Kathrin Fenner, M. Gust, Anette Kuster, Carola KussatzAbstract:The serotonin re-uptake inhibitor fluoxetine was selected for an Environmental risk assessment, using the most recent European guideline (EMEA 2006) within the European Union (EU)-funded Environmental Risk Assessment of Pharmaceuticals (ERAPharm) project due to its Environmental persistence, acute toxicity to nontarget organisms, and unique pharmacokinetics associated with a readily ionizable compound. As a widely prescribed psychotropic drug, fluoxetine is frequently detected in surface waters adjacent to urban areas because municipal wastewater effluents are the primary route of entry to aquatic environments. In Phase I of the assessment, the initial Predicted Environmental Concentration of fluoxetine in surface water (initial PECSW) reached or exceeded the action limit of 10 ng/L, when using both a default market penetration factor and prescription data for Sweden, Germany, and the United Kingdom. Consequently, a Phase II risk assessment was conducted in which green algae were identified as the most sensitive species with a NOEC of <0.6 µg/L. From this value, a Predicted no effect Concentration for surface waters (PNECSW) of 0.012 µg/L was derived. The PEC/PNEC ratio was above the trigger value of 1 in worst-case exposure scenarios indicating a potential risk to the aquatic compartment. Similarly, risks of fluoxetine for sediment-dwelling organisms could not be excluded. No risk assessment was conducted for the terrestrial compartment due to a lack of data on effects of fluoxetine on soil organisms. The need for a separate risk assessment for the main metabolite of fluoxetine, norfluoxetine, was not conducted because of a lack of fate and effect studies. Based on published data, fluoxetine and norfluoxetine appeared to have a low to moderate bioaccumulation potential, which should be confirmed in formal studies according to OECD guidelines. Exposure assessments for fluoxetine according to the current framework rely heavily on KOC and KOW values. This approach is problematic, because fluoxetine is predominantly a cationic substance at Environmental pH values. Consequently, the fate of fluoxetine (and other ionic substances) cannot be Predicted using partition coefficients established for nonionic compounds. Further, published estimates for partition coefficients of fluoxetine vary, resulting in considerable uncertainties in both the exposure and Environmental risk assessments of fluoxetine. Integr Environ Assess Manag 2010;6:524–539. © 2009 SETAC
K.d. Oakes - One of the best experts on this subject based on the ideXlab platform.
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Environmental risk assessment for the serotonin re uptake inhibitor fluoxetine case study using the european risk assessment framework
Integrated Environmental Assessment and Management, 2010Co-Authors: K.d. Oakes, Thomas Knacker, Jeanne Garric, A. Coors, B.i. Escher, Kathrin Fenner, M. Gust, Anette Kuster, Carola KussatzAbstract:The serotonin re-uptake inhibitor fluoxetine was selected for an Environmental risk assessment, using the most recent European guideline (EMEA 2006) within the European Union (EU)-funded Environmental Risk Assessment of Pharmaceuticals (ERAPharm) project due to its Environmental persistence, acute toxicity to nontarget organisms, and unique pharmacokinetics associated with a readily ionizable compound. As a widely prescribed psychotropic drug, fluoxetine is frequently detected in surface waters adjacent to urban areas because municipal wastewater effluents are the primary route of entry to aquatic environments. In Phase I of the assessment, the initial Predicted Environmental Concentration of fluoxetine in surface water (initial PECSW) reached or exceeded the action limit of 10 ng/L, when using both a default market penetration factor and prescription data for Sweden, Germany, and the United Kingdom. Consequently, a Phase II risk assessment was conducted in which green algae were identified as the most sensitive species with a NOEC of <0.6 µg/L. From this value, a Predicted no effect Concentration for surface waters (PNECSW) of 0.012 µg/L was derived. The PEC/PNEC ratio was above the trigger value of 1 in worst-case exposure scenarios indicating a potential risk to the aquatic compartment. Similarly, risks of fluoxetine for sediment-dwelling organisms could not be excluded. No risk assessment was conducted for the terrestrial compartment due to a lack of data on effects of fluoxetine on soil organisms. The need for a separate risk assessment for the main metabolite of fluoxetine, norfluoxetine, was not conducted because of a lack of fate and effect studies. Based on published data, fluoxetine and norfluoxetine appeared to have a low to moderate bioaccumulation potential, which should be confirmed in formal studies according to OECD guidelines. Exposure assessments for fluoxetine according to the current framework rely heavily on KOC and KOW values. This approach is problematic, because fluoxetine is predominantly a cationic substance at Environmental pH values. Consequently, the fate of fluoxetine (and other ionic substances) cannot be Predicted using partition coefficients established for nonionic compounds. Further, published estimates for partition coefficients of fluoxetine vary, resulting in considerable uncertainties in both the exposure and Environmental risk assessments of fluoxetine. Integr Environ Assess Manag 2010;6:524–539. © 2009 SETAC
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Environmental risk assessment for the serotonin re uptake inhibitor fluoxetine: Case study using the european risk assessment framework
Integrated Environmental Assessment and Management, 2010Co-Authors: K.d. Oakes, Jeanne Garric, A. Coors, B.i. Escher, Kathrin Fenner, M. Gust, T. Knacker, Alice Kuster, C. Kussatz, C.d. MetcalfeAbstract:The serotonin re-uptake inhibitor fluoxetine was selected for an Environmental risk assessment, using the most recent European guideline (EMEA 2006) within the European Union (EU)-funded Environmental Risk Assessment of Pharmaceuticals (ERAPharm) project due to its Environmental persistence, acute toxicity to nontarget organisms, and unique pharmacokinetics associated with a readily ionizable compound. As a widely prescribed psychotropic drug, fluoxetine is frequently detected in surface waters adjacent to urban areas because municipal wastewater effluents are the primary route of entry to aquatic environments. In Phase I of the assessment, the initial Predicted Environmental Concentration of fluoxetine in surface water (initial PECSW) reached or exceeded the action limit of 10 ng/L, when using both a default market penetration factor and prescription data for Sweden, Germany, and the United Kingdom. Consequently, a Phase II risk assessment was conducted in which green algae were identified as the most sensitive species with a NOEC of
Kathrin Fenner - One of the best experts on this subject based on the ideXlab platform.
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Environmental risk assessment for the serotonin re uptake inhibitor fluoxetine case study using the european risk assessment framework
Integrated Environmental Assessment and Management, 2010Co-Authors: K.d. Oakes, Thomas Knacker, Jeanne Garric, A. Coors, B.i. Escher, Kathrin Fenner, M. Gust, Anette Kuster, Carola KussatzAbstract:The serotonin re-uptake inhibitor fluoxetine was selected for an Environmental risk assessment, using the most recent European guideline (EMEA 2006) within the European Union (EU)-funded Environmental Risk Assessment of Pharmaceuticals (ERAPharm) project due to its Environmental persistence, acute toxicity to nontarget organisms, and unique pharmacokinetics associated with a readily ionizable compound. As a widely prescribed psychotropic drug, fluoxetine is frequently detected in surface waters adjacent to urban areas because municipal wastewater effluents are the primary route of entry to aquatic environments. In Phase I of the assessment, the initial Predicted Environmental Concentration of fluoxetine in surface water (initial PECSW) reached or exceeded the action limit of 10 ng/L, when using both a default market penetration factor and prescription data for Sweden, Germany, and the United Kingdom. Consequently, a Phase II risk assessment was conducted in which green algae were identified as the most sensitive species with a NOEC of <0.6 µg/L. From this value, a Predicted no effect Concentration for surface waters (PNECSW) of 0.012 µg/L was derived. The PEC/PNEC ratio was above the trigger value of 1 in worst-case exposure scenarios indicating a potential risk to the aquatic compartment. Similarly, risks of fluoxetine for sediment-dwelling organisms could not be excluded. No risk assessment was conducted for the terrestrial compartment due to a lack of data on effects of fluoxetine on soil organisms. The need for a separate risk assessment for the main metabolite of fluoxetine, norfluoxetine, was not conducted because of a lack of fate and effect studies. Based on published data, fluoxetine and norfluoxetine appeared to have a low to moderate bioaccumulation potential, which should be confirmed in formal studies according to OECD guidelines. Exposure assessments for fluoxetine according to the current framework rely heavily on KOC and KOW values. This approach is problematic, because fluoxetine is predominantly a cationic substance at Environmental pH values. Consequently, the fate of fluoxetine (and other ionic substances) cannot be Predicted using partition coefficients established for nonionic compounds. Further, published estimates for partition coefficients of fluoxetine vary, resulting in considerable uncertainties in both the exposure and Environmental risk assessments of fluoxetine. Integr Environ Assess Manag 2010;6:524–539. © 2009 SETAC
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Environmental risk assessment for the serotonin re uptake inhibitor fluoxetine: Case study using the european risk assessment framework
Integrated Environmental Assessment and Management, 2010Co-Authors: K.d. Oakes, Jeanne Garric, A. Coors, B.i. Escher, Kathrin Fenner, M. Gust, T. Knacker, Alice Kuster, C. Kussatz, C.d. MetcalfeAbstract:The serotonin re-uptake inhibitor fluoxetine was selected for an Environmental risk assessment, using the most recent European guideline (EMEA 2006) within the European Union (EU)-funded Environmental Risk Assessment of Pharmaceuticals (ERAPharm) project due to its Environmental persistence, acute toxicity to nontarget organisms, and unique pharmacokinetics associated with a readily ionizable compound. As a widely prescribed psychotropic drug, fluoxetine is frequently detected in surface waters adjacent to urban areas because municipal wastewater effluents are the primary route of entry to aquatic environments. In Phase I of the assessment, the initial Predicted Environmental Concentration of fluoxetine in surface water (initial PECSW) reached or exceeded the action limit of 10 ng/L, when using both a default market penetration factor and prescription data for Sweden, Germany, and the United Kingdom. Consequently, a Phase II risk assessment was conducted in which green algae were identified as the most sensitive species with a NOEC of
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Environmental Risk Assessment of Human Pharmaceuticals in the European Union: A Case Study with the beta-blocker Atenolol
Integrated Environmental Assessment and Management, 2010Co-Authors: Alice Kuster, Jeanne Garric, Kathrin Fenner, A.c. Alder, B. Escher, K. Duis, T.h. Hutchinson, D.r. Lapen, A. Pery, J. RömbkeAbstract:Beta-adrenergic receptor blockers (β-blockers) are applied to treat high blood pressure, ischemic heart disease and heart rhythm disturbances. Due to their widespread use and limited human metabolism β-blockers are widely detected in sewage effluents and surface waters. β-adrenergic receptors have been characterised in fish and other aquatic animals and, therefore, it can be expected that physiological processes regulated by these receptors in wild animals may be affected by the presence of β-blockers. As ecotoxicological data on β-blockers are scarce, it was decided to choose the β-blocker atenolol as a case study pharmaceutical within the project ERAPharm. Starting point for the assessment of potential Environmental risks was the European guideline on the Environmental risk assessment of medicinal products for human use. In Phase I of the risk assessment, the initial Predicted Environmental Concentration (PEC) of atenolol in surface water (500 ng L-1) exceeded the action limit of 10 ng L-1. Thus, a phase II risk assessment was conducted showing acceptable risks for surface water, groundwater and for aquatic microorganisms. Furthermore, atenolol showed a low potential for bioaccumulation as indicated by its low lipophilicity (log Kow = 0.16), a low potential for exposure of the terrestrial compartment via sludge (log Koc = 2.17) and a low affinity for sorption to the sediment. Thus, the risk assessment according to Phase II-Tier A did not reveal any unacceptable risk for atenolol. Beyond the requirements of the guideline, additional data on effects and fate were generated within ERAPharm. A two-generation reproduction test with the waterflea Daphnia magna resulted in the most sensitive NOEC of 1.8 mg L-1. However, even with this NOEC a risk quotient of 0.003 was calculated, which is still well below the risk threshold limit of 1. The additional studies confirm the outcome of the Environmental risk assessment according to EMEA/CHMP (2006). However, atenolol should not be considered as representative for other β-blockers, such as metoprolol, oxprenolol and propranolol some of which show significantly different physico-chemical characteristics and varying toxicological profiles in mammalian studies.